Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001471
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
1999-11-03
Brief Title:
Tissue Biopsy and Imaging Studies in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Virologic and Immunologic Evaluation of Lymph Node Tonsillar and Intestinal Biopsies and Bronchoalveolar Lavage Fluid
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine tissue from the tonsils lymph nodes and large bowel of HIV-infected patients to investigate changes in viral load and certain white blood cells during treatment
Normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study Candidates will be screened with a medical history physical examination blood and urine tests and possibly an electrocardiogram EKG Blood tests may include HLA typing a genetic test of immune system markers
Participants may undergo the following procedures
Blood tests patients and volunteers
Biopsies The frequency of biopsies for given patients may vary depending on their specific therapy Typically biopsies are done at a single time or for patients starting a new therapy biopsies could be performed before starting therapy during therapy and possibly after completion of therapy
Tonsil biopsies patients and volunteers Volunteers will have one tonsil biopsy Patients will have no more than six tonsil biopsies with no more than three in a 10-day period The biopsy is done by an ear nose and throat specialist as an outpatient procedure The tonsils are numbed with a local anesthetic and one to four pieces of tissue are extracted
Lymph node biopsies patients only Patients will have no more than four lymph node biopsies performed no more frequently than once a month The biopsy is done by a surgeon and may require a 2- to 3-day hospital stay The skin above the lymph nodes is numbed with a local anesthetic an incision is made and the tissue is removed Alternatively a needle biopsy may be done in which a small amount of lymph tissue is withdrawn through a special needle injected into the site
Intestinal biopsies patients and volunteers Volunteers will have one intestinal biopsy procedure Patients may have up to six intestinal biopsy procedures each separated by at least 10 days This is done by a gastroenterologist as an outpatient procedure A flexible tube sigmoidoscope or colonoscope with a light and special lens at the tip is inserted into the rectum and large bowel Wire instruments passed through the tube are used to extract small tissue samples
Bronchoalveolar lavage BAL patients and volunteers Volunteers and patients will undergo bronchoscopy in which a flexible tube bronchoscope with a light and special lens at the tip is inserted through the nose or mouth into the lungs and the lining of the lung is sampled by washing the airways with small amounts of saline The procedure is performed by a pulmonologist or critical care specialist usually as an outpatient
Normal volunteers and HIV-infected patients 18 years of age or older may be eligible for this study Candidates will be screened with a medical history physical examination blood and urine tests and possibly an electrocardiogram EKG Blood tests may include HLA typing a genetic test of immune system markers
Participants may undergo the following procedures
Blood tests patients and volunteers
Biopsies The frequency of biopsies for given patients may vary depending on their specific therapy Typically biopsies are done at a single time or for patients starting a new therapy biopsies could be performed before starting therapy during therapy and possibly after completion of therapy
Tonsil biopsies patients and volunteers Volunteers will have one tonsil biopsy Patients will have no more than six tonsil biopsies with no more than three in a 10-day period The biopsy is done by an ear nose and throat specialist as an outpatient procedure The tonsils are numbed with a local anesthetic and one to four pieces of tissue are extracted
Lymph node biopsies patients only Patients will have no more than four lymph node biopsies performed no more frequently than once a month The biopsy is done by a surgeon and may require a 2- to 3-day hospital stay The skin above the lymph nodes is numbed with a local anesthetic an incision is made and the tissue is removed Alternatively a needle biopsy may be done in which a small amount of lymph tissue is withdrawn through a special needle injected into the site
Intestinal biopsies patients and volunteers Volunteers will have one intestinal biopsy procedure Patients may have up to six intestinal biopsy procedures each separated by at least 10 days This is done by a gastroenterologist as an outpatient procedure A flexible tube sigmoidoscope or colonoscope with a light and special lens at the tip is inserted into the rectum and large bowel Wire instruments passed through the tube are used to extract small tissue samples
Bronchoalveolar lavage BAL patients and volunteers Volunteers and patients will undergo bronchoscopy in which a flexible tube bronchoscope with a light and special lens at the tip is inserted through the nose or mouth into the lungs and the lining of the lung is sampled by washing the airways with small amounts of saline The procedure is performed by a pulmonologist or critical care specialist usually as an outpatient
Detailed Description:
Examining tissues outside the bloodstream in HIV-infected patients patients with Idiopathic CD4 lymphopenia ICL and for comparison HIV-uninfected healthy volunteers hereafter referred to as healthy volunteers can provide insights into the pathogenesis of HIV infection and ICL This protocol will provide a mechanism for sampling tissue sites A total of 430 HIV-infected patients 100 ICL patients and 105 healthy volunteers will be enrolled in these studies To assess changes in viral load and immunological parameters at sites outside the bloodstream during therapy of HIV-infected patients sequential tonsillar lymph node or intestinal biopsies or bronchoscopy with bronchoalveolar lavage BAL will be undertaken during the course of therapy In a small number of patients sequential or simultaneous lymph node biopsies will be performed In addition uninfected healthy volunteers will be enrolled to have a tonsillar or intestinal biopsy or bronchoscopy with BAL this will allow comparison of immunologic parameters in HIVinfected and uninfected tonsillar or intestinal tissues or BAL fluid Finally ICL patients may have tissue sampling to assess lymphocyte distribution and possible function in tissues to better understand the pathogenesis of their lymphopenia Sequential or simultaneous tissue sampling may occur and longitudinal samples may also be obtained to assess stability in tissue compartments or effect of possible immunomodulatory treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-I-0027 | None | None | None |